Click here to see Important Safety Information for SOLODYN Tablets.

For Physicians

Welcome

Welcome to your online resource for information about SOLODYN, the most prescribed branded medication in dermatology.1

SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.

Extended release SOLODYN Tablets are approved in eight strengths for more precise weight-based dosing of SOLODYN that narrows the actual dose ranges toward the target of 1 mg/kg/day for patients with non-nodular, moderate to severe inflammatory acne 12 years and older weighing 99-300 lbs. SOLODYN Tablets are approved in 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg.2

In clinical trials of the 45 mg, 90 mg, and 135 mg strengths with 1,038 patients, SOLODYN demonstrated efficacy in a low dose (1 mg/kg/day).5,6 There was no evidence of improved efficacy with 2 mg/kg/day and 3 mg/kg/day.5 Higher doses of SOLODYN have not been shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular adverse events.2 Clinical studies also showed that SOLODYN Tablets were well-tolerated, with an adverse event profile similar to placebo.2

  • In a Phase 2 dose-response study of 233 subjects with the 45 mg, 90 mg, and 135 mg strengths, 1 mg/kg/day extended-release SOLODYN Tablets provided statistically significant inflammatory lesion reduction vs. placebo (n=114, 56.8% vs. 39.4%, p=0.015).5
  • In two Phase 3 clinical studies with the 45 mg, 90 mg, and 135 mg strengths, the mean percent improvement in inflammatory lesions was greater in patients treated with SOLODYN Tablets than with placebo (Study 1, n=451, 43.1% vs. 31.7%, p=0.001; Study 2, n=473, 45.8% vs. 30.8%, p<0.001, respectively).6
  • There was no evidence of improved efficacy with 2 mg/kg/day and 3 mg/kg/day.5

Demonstrated Efficacy in Clinical Trials with 1,038 Patients
Mean Percent Change from Baseline in Inflammatory Lesion Counts6

The most commonly reported adverse events were headache, fatigue, dizziness, and pruritus.

Adverse Event Profile Similar to Placebo
In clinical studies, extended-release SOLODYN Tablets were well-tolerated.2

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Email:customer_service@Medicis.com
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Corporate Headquarters: Medicis, The Dermatology Company
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Scottsdale, AZ 85256-2740

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Indication and Usage

SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.

Important Safety Information for SOLODYN Tablets
  • The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus.
  • Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman.
  • Tetracycline drugs should not be used during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth.
  • Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
  • Central nervous system side effects, including light-headedness, dizziness, and vertigo, have been reported with minocycline therapy.
  • In rare cases, photosensitivity has been reported.
  • Should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.
  • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • Safety beyond 12 weeks of use has not been established.
  • Cases of anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms have been reported postmarketing with minocycline use. Discontinue SOLODYN immediately if symptoms occur.